Acupuncture For Pancreatic Cancer Pain: A Randomized Phase III Study


Phase 3
N/A
N/A
Not Enrolling
Both
Pancreatic Neoplasms, Pain

Thank you

Trial Information

Acupuncture For Pancreatic Cancer Pain: A Randomized Phase III Study


The main aim of this pancreatic cancer pain trial is to determine the effects of a single,
practitioner-given acupuncture treatment followed by semi-permanent acupuncture studs. Our
primary endpoint is subjective; therefore, a placebo control will be applied with patients
blinded to treatment allocation.

In clinical practice, acupuncturists individualize treatment: two patients with a similar
conventional diagnosis may receive different point prescriptions depending on the
acupuncture differential diagnosis. Randomized trials of acupuncture can either prescribe a
fixed treatment formula in terms of the number of sessions and points to be used, or allow
practitioners to exercise clinical judgment in individualizing care. There has been
considerable debate in the methodological literature about the merits of each approach. The
use of a fixed treatment schedule increases the reproducibility of the findings but is said,
by practitioners, to generally reduce treatment effectiveness. In this trial, we have
developed an approach that allows practitioners to individualize treatments in a manner that
allows exact replication, by specifying particular point locations to be used depending on
the sites where a patient experiences pain. Point locations for this and for all of our
acupuncture studies are determined by our licensed, credentialled acupuncturists.

Following accrual of the initial 10-15 patients, we will review treatment compliance,
blinding and accrual. Adjustments will be made to deal with compliance issues, to facilitate
placebo blinding, or deal with recruitment problems for the remainder of the study.


Inclusion Criteria:



- Diagnosis of pancreatic adenocarcinoma.

- First baseline current pain score of 3 or above on a 0 – 10 numerical rating scale.

- In the opinion of the treating physician or a medically qualified investigator, the
patient’s pain syndrome is the result of underlying cancer.

- Patient OR caregiver must be willing and able to apply pressure to each point using
small circular movements with the fingers twice per day.

Exclusion Criteria:

- Primary cause of pain is procedural (e.g. postoperative pain).

- Acupuncture treatment in the past six weeks. Patients should not receive acupuncture
during the one week period of the study.

- Neutropenia defined as absolute neutrophil count (ANC) <1000/microliter.

- Cardiac conditions constituting high or moderate risk of endocarditis as defined by
the American Heart Association criteria.

- Patient contraindicated for phlebotomy, as phlebotomy needles are much larger than
acupuncture needles.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

To determine whether acupuncture reduces pain in pancreatic cancer patients more effectively than placebo

Principal Investigator

Barrie R. Cassileth, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

03-106

NCT ID:

NCT00136669

Start Date:

September 2003

Completion Date:

September 2005

Related Keywords:

  • Pancreatic Neoplasms
  • Pain
  • Acupuncture
  • Pain
  • Pancreatic Neoplasms
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021